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ADULTS WHO STUTTER NEEDED
FOR CLINICAL RESEARCH STUDY
Adults who stutter are being sought by researchers for a study to evaluate the safety, effectiveness and tolerability of pagoclone, an investigational medication for the potential treatment of adults who stutter. To determine whether you or someone you know may qualify for the study, please visit www.StutteringStudy.com or call 866-469-0444.
Stuttering is a speaking disorder affecting an estimated three million Americans – approximately one percent of the population. It can cause high levels of social anxiety in individuals, particularly in speaking situations, and affects four times as many men as women. Stuttering is often characterized by interruptions in the flow of speech by repetition of syllables, prolongation of sounds or unplanned stoppages. The cause is not clearly understood and varies among individuals. Some research in the last decade suggests that stuttering may result from disruption to the brain's speech pathway during earlier developmental years.
"Stuttering can have a tremendous impact on a person's life: their social functioning, their occupational achievement," said Dr. Gerald A. Maguire, a lead investigator of the pagoclone stuttering study and Associate Professor of Clinical Psychiatry at the University of California, Irvine School of Medicine. "The treatment challenge for the future is not only to improve fluency, but to reduce the individual's anxiety and avoidances of certain feared speaking situations."
Safety and efficacy data from a previous pagoclone clinical trial were presented at the 2008 National Stuttering Association meeting as well as to the Oxford Dysfluency meeting in England. The new research study is designed to determine whether adults treated with the investigational medication, pagoclone, experience a reduction in stuttered syllables compared to those administered a placebo (an inactive medication or "sugar pill").
"As the largest support organization for people who stutter, the National Stuttering Association advocates research into effective treatments for stuttering," said Jim McClure, media relations director for the association. "While we do not endorse specific treatments, we are excited about the prospect of a future medication that may help some people who stutter improve their fluency which in turn may help the individual to gain self-confidence."
Pagoclone is a novel, non-benzodiazepine, selective GABA-A receptor agonist that was originally developed and investigated as a potential treatment for generalized anxiety disorder and panic disorder. During the clinical study, it was observed that a few participants with a history of stuttering experienced less stuttering while taking the investigational drug.
"Pagoclone works with the chemical GABA or gamma amino butyric acid, a neuro-chemical involved with mediating anxiety and potentially fine muscle motion. In this way, we believe it may affect the mechanism that ultimately improves stuttering symptoms," said Dr. Maguire.
"If this study is successful, future investigations may combine study medication with speech therapy to determine whether that will lead to better results," said Dr. Maguire.
Approximately 330 people who stutter will be enrolled to receive either pagoclone or a placebo. The research study will require six office visits and four telephone check-ins over an eight-month period. At the end of the eight-month treatment period, participants may have an option to choose to continue in an extension of the study in which all participants will receive the investigational medication, pagoclone, for approximately 12 months. All study-related doctor's visits, procedures and study medication will be provided at no cost. The participants may receive compensation for travel-related expenses.
To be eligible for the current pagoclone clinical study, participants must be between the ages of 18 and 80 and have a history of stuttering prior to the age of eight. All adults must be English speaking with an eighth grade education level and meet additional eligibility requirements. Details are available at www.StutteringStudy.com or by phoning 866-469-0444.
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NOTE TO REPORTERS, EDITORS AND PRODUCERS: Local physicians and individuals who stutter are available for interviews upon request. Also available for broadcast use, is background video footage featuring Dr. Gerald Maguire, Associate Professor of Clinical Psychiatry at the University of California, Irvine School of Medicine and two individuals who stutter.